- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01270269
ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit (ACT-ICU)
Study Overview
Status
Conditions
Detailed Description
The long-term consequences of critical illness and intensive care unit (ICU) hospitalization in ICU survivors are profound and include cognitive, physical, and functional impairments. The purpose of this study is to pilot test a multi-component, cognitive and physical rehabilitation program beginning in the ICU, combined with a 12-week home-based cognitive rehabilitation program following hospital discharge to determine whether participation in a rehabilitation program will result in improved outcomes among ICU survivors. The study will rely on a randomized controlled clinical trial design, with patients assigned to one of three groups: a "usual care" control group, an early physical activity group (without cognitive therapy), or an early cognitive therapy and physical activity group. All individuals in the intervention groups will receive protocolized physical therapy while hospitalized. In addition, individuals in the early cognitive therapy and physical activity group will receive cognitive therapy starting in the ICU and continuing for 12 weeks once a patient leaves the hospital. In-home visits will occur every other week during the 12-week intervention period.
The study's primary outcome is executive functioning (e.g. ability to plan, organize, multi-task) at 3-months following hospital discharge as measured by the Tower Test, a psychometric tool evaluating executive abilities. This has been chosen due to the fact that available research points to the presence of significant deficits in executive functioning among ICU survivors. Secondary outcomes include global cognitive function, physical function and Health Related Quality of Life by assessing scores on the following measures: Katz's ADL, Functional Activities Questionnaire, AD8, Short-Informant Questionnaire of Cognitive Decline in the Elderly, Clinical Dementia Rating Scale (if performed), Timed Up & Go test, Mini-Mental State Exam, Dysexecutive Questionnaire, Activities-Specific Balance Confidence Scale, Behavior Rating Inventory of Executive Function, Behavior Pain Inventory, Trails A & B test, Repeatable Battery for Assessment of Neuropsychological Status, General Employment Questionnaire, Beck Depression Inventory II, Post-traumatic stress checklist, Short Form 36, Canadian Study of Health and Aging and patient weight, and Tower Test score at 12 month follow-up. We will also track readmission to the hospital and admission to a nursing home or skilled rehabilitation facility as secondary outcomes during the 12-month follow-up period. The study duration will include 1 year of enrollment and 1 year for study completion following enrollment of the final patient.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients admitted to the medical or surgical ICU who are receiving treatment for respiratory failure, cardiogenic shock, hemorrhagic shock, and/or septic shock.
Exclusion Criteria:
- Moderate to severe dementia on ICU admission based on a standardized surrogate assessment (as this would prohibit patients from functioning independently at home);
- Moderate or severe physical dysfunction that precludes performance of independent activities of daily living based on a standardized surrogate assessment;
- Live greater than 120 miles from Nashville;
- Blind, deaf, or unable to speak English;
- Prisoners;
- Homelessness and no secondary contact person available
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Patients (Controls)
Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.
|
|
Experimental: Behavioral: Phys & Func Rehab
A multi-component program of physical rehabilitation interventions (without cognitive rehabilitation) will be delivered to patients beginning in the ICU and continue throughout the hospitalization.
|
A multi-component program of physical rehabilitation interventions (without cognitive rehabilitation) will be delivered to patients beginning in the ICU and continue throughout the hospitalization.
Other Names:
|
Experimental: Behavioral: Cog/Phys/Func Rehab
A multi-component program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients beginning in the ICU with continued cognitive rehabilitation in their home environments over a focused 12-week period.
|
A multi-component program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients beginning in the ICU with continued cognitive rehabilitation in their home environments over a focused 12-week period.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tower Test
Time Frame: 3 months post hospital discharge
|
A psychometric measure of executive functioning.
|
3 months post hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go (TUG)
Time Frame: 3 months post hospital discharge
|
A timed test assessing physical strength and gait speed.
|
3 months post hospital discharge
|
Functional Activities Questionnaire
Time Frame: 3 months post hospital discharge
|
A brief measure of higher order (IADL) functioning.
|
3 months post hospital discharge
|
EQ-5 Global Scores
Time Frame: 3 months post hospital discharge
|
The EQ-5 Global Scores is an assessment of quality of life.
|
3 months post hospital discharge
|
Katz Activities of Daily Living (ADL) scale
Time Frame: 3 months post hospital discharge
|
A six-item tool assessing the degree of independence vs. dependence in basic activities of daily living.
|
3 months post hospital discharge
|
Activities-Specific Balance Confidence Scale (ABC)
Time Frame: 3 months post hospital discharge
|
A brief rating scale that asks participants to rate how confident they are that they can maintain their balance and remain steady while engaged in 16 non-hazardous tasks.
|
3 months post hospital discharge
|
AD8
Time Frame: 3 months post hospital discharge
|
A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities.
|
3 months post hospital discharge
|
Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE)
Time Frame: 3 months post hospital discharge
|
A measure of cognitive functioning that evaluates the degree of decline from baseline and which is complementary to the AD8.
This measure will only be used in patients over the age of 50 who had any problems with memory or thinking prior to current illness.
|
3 months post hospital discharge
|
Mini Mental State Exam (MMSE)
Time Frame: 3 months post hospital discharge
|
A widely used measure of overall cognitive functioning that briefly samples abilities in a wide array of areas including memory and attention.
|
3 months post hospital discharge
|
Dysexecutive Questionnaire (Dys Exec)
Time Frame: 3 months post hospital discharge
|
A questionnaire, which has both patient and surrogate versions, that assesses patient functioning in a number of functional areas sensitive to executive dysfunction.
|
3 months post hospital discharge
|
TRAILS A & B Test
Time Frame: 3 months post hospital discharge
|
Two widely used to test the speed that it takes to connect a series of numbers (Part A) and numbers alternating with letters (Part B).
|
3 months post hospital discharge
|
General and Employment Questionnaire
Time Frame: 3 months post hospital discharge
|
A brief series of questions which pertain to patient history and demographics and which also inquire about employment both before and after ICU hospitalization.
|
3 months post hospital discharge
|
Canadian Study of Health and Aging (CHSA) Frailty Scale
Time Frame: 3 months post hospital discharge
|
A brief global rating scale of frailty based on clinical impression.
|
3 months post hospital discharge
|
Tower Test
Time Frame: 12 months post hospital discharge
|
A psychometric measure of executive functioning.
|
12 months post hospital discharge
|
Timed Up and Go (TUG)
Time Frame: 12 months post hospital discharge
|
A timed test assessing physical strength and gait speed.
|
12 months post hospital discharge
|
Functional Activities Questionnaire
Time Frame: 12 months post-hospital discharge
|
A brief measure of higher order (IADL) functioning.
|
12 months post-hospital discharge
|
EQ-5 Global Scores
Time Frame: 12 months post hospital discharge
|
The EQ-5 Global Scores is an assessment of quality of life.
|
12 months post hospital discharge
|
Katz Activities of Daily Living (ADL) scale
Time Frame: 12 months post hospital discharge
|
A six-item tool assessing the degree of independence vs. dependence in basic activities of daily living.
|
12 months post hospital discharge
|
Activities-Specific Balance Confidence Scale (ABC)
Time Frame: 12 months post hospital discharge
|
A brief rating scale that asks participants to rate how confident they are that they can maintain their balance and remain steady while engaged in 16 non-hazardous tasks.
|
12 months post hospital discharge
|
AD8
Time Frame: 12 months post hospital discharge
|
A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities.
|
12 months post hospital discharge
|
Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE)
Time Frame: 12 months post hospital discharge
|
A measure of cognitive functioning that evaluates the degree of decline from baseline and which is complementary to the AD8.
This measure will only be used in patients over the age of 50 who had any problems with memory or thinking prior to current illness.
|
12 months post hospital discharge
|
Mini Mental State Exam (MMSE)
Time Frame: 12 months post hospital discharge
|
A widely used measure of overall cognitive functioning that briefly samples abilities in a wide array of areas including memory and attention.
|
12 months post hospital discharge
|
Dysexecutive Questionnaire (Dys Exec)
Time Frame: 12 months post hospital discharge
|
A questionnaire, which has both patient and surrogate versions, that assesses patient functioning in a number of functional areas sensitive to executive dysfunction.
|
12 months post hospital discharge
|
TRAILS A & B Test
Time Frame: 12 months post hospital discharge
|
Two widely used to test the speed that it takes to connect a series of numbers (Part A) and numbers alternating with letters (Part B).
|
12 months post hospital discharge
|
General and Employment Questionnaire
Time Frame: 12 months post hospital discharge
|
A brief series of questions which pertain to patient history and demographics and which also inquire about employment both before and after ICU hospitalization.
|
12 months post hospital discharge
|
Canadian Study of Health and Aging (CHSA) Frailty Scale
Time Frame: 12 months post hospital discharge
|
A brief global rating scale of frailty based on clinical impression.
|
12 months post hospital discharge
|
Mortality
Time Frame: 2 months post hospital discharge
|
2 months post hospital discharge
|
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Rehospitalization rate and number of hospital days
Time Frame: 12 months post hospital discharge
|
12 months post hospital discharge
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nathan E. Brummel, MD, Vanderbilt University School of Medicine
Publications and helpful links
General Publications
- Jackson JC, Ely EW, Morey MC, Anderson VM, Denne LB, Clune J, Siebert CS, Archer KR, Torres R, Janz D, Schiro E, Jones J, Shintani AK, Levine B, Pun BT, Thompson J, Brummel NE, Hoenig H. Cognitive and physical rehabilitation of intensive care unit survivors: results of the RETURN randomized controlled pilot investigation. Crit Care Med. 2012 Apr;40(4):1088-97. doi: 10.1097/CCM.0b013e3182373115.
- Brummel NE, Jackson JC, Girard TD, Pandharipande PP, Schiro E, Work B, Pun BT, Boehm L, Gill TM, Ely EW. A combined early cognitive and physical rehabilitation program for people who are critically ill: the activity and cognitive therapy in the intensive care unit (ACT-ICU) trial. Phys Ther. 2012 Dec;92(12):1580-92. doi: 10.2522/ptj.20110414. Epub 2012 May 10.
- Schweickert WD, Herlitz J, Pohlman AS, Gehlbach BK, Hall JB, Kress JP. A randomized, controlled trial evaluating postinsertion neck ultrasound in peripherally inserted central catheter procedures. Crit Care Med. 2009 Apr;37(4):1217-21. doi: 10.1097/CCM.0b013e31819cee7f.
- Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Rehabilitation
- Pathologic Processes
- Aging
- Central Nervous System Diseases
- Musculoskeletal Diseases
- Sepsis
- Critical Illness
- Neurologic Manifestations
- Muscular Diseases
- Delirium
- Brain Diseases
- Wounds and Injuries
- Signs and Symptoms
- Respiratory Failure
- Muscle Weakness
- Brain Injuries
- Neuromuscular Manifestations
- Craniocerebral Trauma
- Asthenia
- Immobility
- Trauma, Nervous System
- Critical Illness Myoneuropathy
- Over-sedation
- Disorders of Environmental Origin
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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